Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000745448
Ethics application status
Approved
Date submitted
31/05/2016
Date registered
6/06/2016
Date last updated
26/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can video training improve the accuracy of self-performed joint counts in rheumatoid arthritis for remote disease monitoring?
Scientific title
See one, do one? Can video training improve the accuracy of self-performed joint counts in rheumatoid arthritis for remote disease monitoring?
Secondary ID [1] 289341 0
Nil
Universal Trial Number (UTN)
U1111-1183-4954
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 298961 0
Condition category
Condition code
Inflammatory and Immune System 299030 299030 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will view a short (<5-8 minutes) online video on a smartphone while waiting for their rheumatology clinic appointment in the public hospital study sites. The video will teach people with RA how to examine 28 key joints to determine the presence or absence of "tenderness" and/or "swelling" in these joints. The exact content of the video will be determined by rheumatologists and people with rheumatoid arthritis in a co-design workshop (planned for August 2016).
A research assistant will provide the smartphone with the app RAConnect loaded, through which each participant will complete a tender and swollen joint count, following instructions within the app. Then participants randomized to the “video training” intervention will watch the video, via link in RAConnect, then complete the tender and swollen joint count again. The intervention will occur once only and with individual participants.
Intervention code [1] 294902 0
Diagnosis / Prognosis
Comparator / control treatment
No viewing of video
Control group
Active

Outcomes
Primary outcome [1] 298490 0
Participant self reports number of tender or swollen joints using smartphone application. This is compared to joint count determined by rheumatologist during clinical evaluation. Delta of ICC for patient joint count compared with rheumatologist joint count, between group difference for groups 1. two tender and swollen joint counts with no training and 2. first tender and swollen joint joint with no training, then video training, then second joint count after watching video joint count training
Timepoint [1] 298490 0
Single clinic visit, patient self-joint counts performed Immediately before clinic visit
Secondary outcome [1] 324358 0
Bland Altman plot for patient and rheumatologist derived DAS-28 CRP
Timepoint [1] 324358 0
Single clinic visit, patient self-joint counts performed Immediately before clinic visit

Eligibility
Key inclusion criteria
Potential participants are people with rheumatoid arthritis and fluent in English attending rheumatology outpatient clinics where the rheumatologist in this study are in attendance (PI and CIs in this study).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Declines to give informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Rheumatologist will be blinded to participant group allocation and participant self-reported joint counts
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequential sealed envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Inter-rater reliability for patient-performed tender and swollen 28 joint counts compared with rheumatologist performed joint counts, before and after viewing video for people randomised to 1. performs joint counts, watches video, second joint count and 2. performs two joint counts without any training/education. Primary outcome of interest is difference in change in ICC between the two groups.
Previous studies suggest that the ICC between patients and health care professionals is between 0.70 and 0.92 for TJC and between 0.30 and 0.55 for SJC (1). Short training changes the ICC for patient and physician TJC from 0.33 to 0.48 and the ICC for patient and physician SJC from 0.66 to 0.84 (13) From SD Walter, M Eliasziw and A Donner, “Sample Size and Optimal Designs for Reliability Studies,” a sample size of 50 patients per group will provide 80% power to detect an improvement of ICC for TJC from from 0.66 to 0.84, at the 0.05 level of significance (2). Fifty patient per group will give an 80% power to detect and improvement of ICC between groups of 0.33 to 0.48 for SJC at the 0.05 level of significance. We therefore plan to recruit 100 patients for this study and randomly assign to the training (Group B) or no-training group (Group A). This will also provide enough data to be able to estimate the final ICC to within + 0.2 (3).

(1) Cheung PP, Gossec L, Mak A, March L. Reliability of joint count assessment in rheumatoid arthritis: a systematic literature review. Semin Arthritis Rheum. Elsevier; 2014 Jun;43(6):721–9.
(2) Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101–10.
(3)Wolak ME, Fairbairn DJ, Paulsen YR. Guidelines for estimating repeatability. Methods in Ecology and Evolution. 2011 Jun 2;3(1):129–37.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/07/2017
Actual
30/10/2017
Date of last participant enrolment
Anticipated
29/12/2017
Actual
27/03/2018
Date of last data collection
Anticipated
29/12/2017
Actual
27/03/2018
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 7929 0
New Zealand
State/province [1] 7929 0
Wellington
Country [2] 7930 0
New Zealand
State/province [2] 7930 0
Christchurch
Country [3] 7931 0
New Zealand
State/province [3] 7931 0
Dunedin

Funding & Sponsors
Funding source category [1] 293719 0
University
Name [1] 293719 0
University of Otago
Country [1] 293719 0
New Zealand
Primary sponsor type
University
Name
University of Otago Wellington
Address
Department of Medicine
23A Mein St
PO Box 7343
Wellington South 6242
Country
New Zealand
Secondary sponsor category [1] 292551 0
None
Name [1] 292551 0
none
Address [1] 292551 0
none
Country [1] 292551 0
Other collaborator category [1] 279010 0
Hospital
Name [1] 279010 0
Hutt Hospital (Hutt Valley DHB)
Address [1] 279010 0
High Street,
Lower Hutt, 5010

Hutt Valley DHB,
Private Bag 31907,
Lower Hutt 5010
Country [1] 279010 0
New Zealand
Other collaborator category [2] 279011 0
Hospital
Name [2] 279011 0
Dunedin Hospital (Southern DHB)
Address [2] 279011 0
201 Great King Street, Dunedin 9016
Country [2] 279011 0
New Zealand
Other collaborator category [3] 279012 0
Hospital
Name [3] 279012 0
Christchurch Hospital (Canterbury DHB)
Address [3] 279012 0
2 Riccarton Ave, Christchurch Central, Christchurch 4710
Country [3] 279012 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295151 0
HDEC NZ
Ethics committee address [1] 295151 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 295151 0
New Zealand
Date submitted for ethics approval [1] 295151 0
03/06/2016
Approval date [1] 295151 0
05/07/2016
Ethics approval number [1] 295151 0
16/NTB/102

Summary
Brief summary
Objectives
To assess if a video designed to train people with rheumatoid arthritis (RA) to perform their own tender and swollen joint counts improves concordance of patient-reported tender and swollen joint counts with those performed by their rheumatologist
Hypothesis
After watching a video designed to train people with rheumatoid arthritis (RA) to perform their own tender and swollen joint counts, self-performed joint counts will have sufficient concordance with rheumatologist performed joint counts that patient reported joint counts are likely to be acceptably accurate in remote monitoring of RA.
Design
One hundred people with RA will be recruited as they attend their usual rheumatology clinics in public hospitals in Wellington, Christchurch and Dunedin. Before the appointment with their rheumatologist participants will record their own RA disease activity including 28 tender joint count (TJC) and swollen joint count (SJC) imputed to into a mobile health application (an app) RAConnect. They will then be randomised in a 1:1 ratio to 1. Repeating the self-28 TJC and SJC in RAConnect or 2. Viewing the joint count training video in RAConnect then repeating the the self-28 TJC and SJC in RAConnect. During the clinic appointment their rheumatologist will record the physician-performed 28 TJC and SJC, blinded to patient self-joint counts and allocated group. Concordance of patient self-joint counts with rheumatologists joint counts for the first and second joint count will be assessed.
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66318 0
Dr Rebecca Grainger
Address 66318 0
Department of Medicine, University of Otago, Wellington, 23a Mein St, Newtown, PO Box 7343, Wellington South 6242
Country 66318 0
New Zealand
Phone 66318 0
+64 4 385 5541
Fax 66318 0
Email 66318 0
[email protected]
Contact person for public queries
Name 66319 0
Dr Rebecca Grainger
Address 66319 0
Department of Medicine, University of Otago, Wellington, 23a Mein St, Newtown, PO Box 7343, Wellington South 6242
Country 66319 0
New Zealand
Phone 66319 0
+64 4 385 5541
Fax 66319 0
Email 66319 0
[email protected]
Contact person for scientific queries
Name 66320 0
Dr Rebecca Grainger
Address 66320 0
Department of Medicine, University of Otago, Wellington, 23a Mein St, Newtown, PO Box 7343, Wellington South; 6242
Country 66320 0
New Zealand
Phone 66320 0
+64 4 385 5541
Fax 66320 0
Email 66320 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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